Favrille (FVRL) completed enrollment in its pivotal Phase 3 clinical trial of FavId.
The news comes two weeks after shares of the tiny San Diego biotech jumped 33% in a day on news that U.S. regulators had given the cancer drug so-called fast track status.
Initiated in July 2004, the registration trial is designed to evaluate FavId following Rituxan therapy for the treatment of follicular B-cell non-Hodgkin's lymphoma.
Favrille anticipates an analysis of the secondary endpoint of this Phase 3 trial, response improvement, during the fourth quarter of this year. According to Favrille's Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration, a clinically meaningful response improvement may be the basis for accelerated approval. Analysis of the primary endpoint of the trial, time to disease progression, is expected during the second half of 2007.